A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAstraZeneca

About this trial

The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there is any effect of eating compared to fasting (food effect) in healthy adults.

Eligibility criteria

Qualifiers

Healthy male and female participants aged 18 to 55 years at the time of signing consent.

All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.

Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.

Have a Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.

Disqualifiers

History of any clinically important disease or disorder.

History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to laroprovstat or ezetimibe.

Treatment with any lipid lowering therapy or laroprovstat within the 3 months prior to the Screening Visit.

Trial design

Treatments tested in this trial

  • Laroprovstat/ezetimibe FCDP
  • Laroprovstat STP
  • Ezetimibe STP
  • Laroprovstat/ezetimibe FCDP-slow variant

Treatment groups

18 Participants
are divided into 4 treatment groups

Sponsors and collaborators